Investigating the link between dopamine transmission and reality-monitoring abilities

MONITORING OF REALITY AND DOPAMINE: A PHARMACOLOGICAL RESEARCH

This study is testing if a new brain stimulation treatment can help people with schizophrenia and Parkinson's disease better tell the difference between real experiences and imagined ones by looking at how dopamine affects their thinking.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Hôpital le Vinatier (Academic / other)
• Locations: 1 site (Bron)
• Trial ID: NCT05711082 on ClinicalTrials.gov

What this trial studies

This study explores the relationship between dopamine (DA) transmission and reality-monitoring, which is the ability to distinguish between real experiences and imagined ones. It focuses on individuals with schizophrenia and Parkinson's disease, as impaired reality-monitoring is often associated with hallucinations in these populations. The study will utilize fronto-temporal transcranial Direct Current Stimulation (tDCS) and various dopamine-related interventions to assess their effects on reality-monitoring performance. The goal is to establish a direct link between DA transmission and reality-monitoring abilities.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy volunteers aged 18 to 45 who are fluent in French and have normal or corrected vision.

Not a fit: Patients with any past or current psychiatric or neurological conditions, or those with significant medical issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved treatments for hallucinations in patients with schizophrenia and Parkinson's disease.

How similar studies have performed: While there have been studies linking dopamine transmission to hallucinations, this specific approach exploring the direct connection with reality-monitoring is novel.

Eligibility criteria

Inclusion Criteria:

* Healthy volunteers who have given their written informed consent
* Men and women from 18 to 45 years old
* Normal or corrected vision
* Being fluent in French or French for native language
* Being affiliated with health insurance

Exclusion Criteria:

* Healthy volunteers who have given their written informed consent
* Men and women from 18 to 45 years old
* Normal or corrected vision
* Being fluent in French or French for native language
* Being affiliated with health insurance
* Inadmissibility of the subject's consent or refusal
* Working-memory deficit (as controlled with MMSE score\< 23)
* Any past or current psychiatric or somatic condition(as controlled with the Mini International Neuropsychiatric Interview, MINI)
* Any past or current neurological condition
* History of cranio-cerebral trauma, arterial hypotension or hypertension, cardiological or serious medical condition
* Abnormal potassium dosage (below 3.1 mmol/L or above 4.9 mmol/L)
* Anormal ECG
* History of schizophrenia or bipolar disorder in first-degree relatives
* Alcohol-drinking and caffeine intake at least during 24 hours before each session
* Drug therapy excepting contraceptives
* Cardiologic or severe medical conditio
* Pregnancy(checked with a pregnancy autotest), lactation, or insufficient contraceptive measure (precautionary measure)
* Consumption of recreational drugs during the last 6 months
* Known sensitivity to any of the study medication and their excipients
* Lactose intolerance
* Porphyria
* Hepatic insufficiency

Where this trial is running

Bron

• Centre Hospitalier le Vinatier — Bron, France (Recruiting)

Study contacts

• Principal investigator: Filipe Galvao — Centre Hospitalier le Vinatier
• Study coordinator: Jerome Brunelin

Conditions Neurosciences